Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
August 17, 2026 updated by: Austin Kirschner, Vanderbilt-Ingram Cancer Center
Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed).
Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors.
Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform.
Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.
II. To assess the durability of response using an established method (modified Severity-Weight Assessment [mSWAT] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.
III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique.
OUTLINE:
The investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21.
After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The high volume of cutaneous lymphoma patients seen at Vanderbilt makes it likely to significantly contribute to the knowledge about this treatment technique.
Given the rarity of this disease, with Vanderbilt being a major treatment center for mycosis fungoides, the goal is to systematically contribute to the data for low-dose total skin electron therapy in order to prospectively assess these endpoints.
It is expected to find skin manifestations of mycosis fungoides that are refractory or have relapsed on at least one prior therapy.
Patients with prior skin electron therapy, including either high or low-dose total skin electron therapy, are permitted on this protocol if the radiation oncologist determines that low-dose radiation therapy can safely carried out.
The goal is to assess quality of life and accurately grade skin findings following this non-experimental, standard of care, total skin electron radiation treatment.
Description
Inclusion Criteria:
- Biopsy confirmed mycosis fungoides stage IB-IIIA
- Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids
- Life expectancy > 6 months
Exclusion Criteria:
- Serious medical condition that would make treatment unsafe
- Pregnant or lactating patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Quality of Life/ Grading Skin Findings
Patients' baseline quality of life is established by completion of an initial questionnaire, and skin lesion burden is quantified by physical examination using a recommended system .
Following the standard of care radiation therapy, patients' completion of questionnaire, and physical examination is repeated for continued assessment.
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At initial visit (day 1) - for determination of a baseline quality of life, patients will be given a self-reported questionnaire called the Skindex-29.
Following standard of care radiation treatments, at weeks 6 & 12, and every 3 months thereafter, patients will complete the Skindex-29 questionnaire.
At initial visit (day 1) , using mSWAT the radiation oncologist can follow the patient's treatment response by accurately grading the severity of the patient's skin findings.
Following standard of care radiation treatments, at weeks 6 & 12, and every 3 months thereafter, mSWAT will again be determined by physician.
Follow-up visits will continue until patient has a change in disease.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in skin-related quality of life assessed by Skindex-29
Time Frame: Baseline to up to 3 years
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Skindex-29 is a validated quality of life questionnaire to help quantify how mycosis fungoides may affect one's quality of life on a day to day basis, including emotional impact of the skin disease.
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Baseline to up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the durability of response assessed by mSWAT tool
Time Frame: Baseline to up to 3 years
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mSWAT is the Modified Severity Weighted Assessment Tool used by the radiation oncologist during complete physical examination to quantify skin findings of patches, plaques, and tumors in all regions of the body; this would help the radiation oncologist and dermatologist to better follow the response to treatment.
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Baseline to up to 3 years
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Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique
Time Frame: Up to 3 years
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The patient will be closely monitored by the radiation oncologist during treatment, with at least 2-3 visits while patient is on treatment.
Side effects will be documents in patient medical records.
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Up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Austin Kirschner, MD, PhD, Vanderbilt-Ingram Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2016
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2030
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
March 2, 2016
First Posted (Estimated)
March 8, 2016
Study Record Updates
Last Update Posted (Actual)
August 19, 2026
Last Update Submitted That Met QC Criteria
August 17, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC RAD 1633
- P30CA068485 (U.S. NIH Grant/Contract)
- NCI-2015-02293 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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